An interventional study of Remote Ischemic Conditioning and Sham Remote Ischemic Conditioning in Stroke, Acute, Ischemic Stroke and Cerebrovascular Disorders, sponsored by Grethe Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by Grethe Andersen · Not applicable, Interventional, and Treatment
Among 51 studies in Ischemic Stroke with a site in Denmark — 12 open to participants now, 15 under way, 3 of them phase 3. Ischemic Stroke · Denmark.
Among the 51 studies in Ischemic Stroke with a site in Denmark, this one is the 29th largest by enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2020, is one of 18 with no phase, and was the 34th registered.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
Browse Ischemic Stroke studies →12 of the 51 studies in Ischemic Stroke with a site in Denmark are open now. Recruiting first, the newest first:
Guri Hagberg · Sites in Denmark, Norway, Sweden
Ages 18+
University of L'Aquila · Sites in Denmark, Croatia, Egypt and 12 more countries
Ages 18+
Odense University Hospital · Sites in Denmark
Ages 18+
Hamilton Health Sciences Corporation · Sites in Denmark, United States, Belgium and 9 more countries
Ages 18+
Aarhus University Hospital · Sites in Denmark
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 8 · Phase 3 9 · Phase 4 2
First in 2008; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Median enrollment 224 across the 36 interventional studies, 180 across the 15 observational. Of the 30 that completed or were terminated, 9 (30%) have results posted.
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13 of 51 have an industry lead sponsor. The 10 most frequent:
Grethe Andersen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Grethe Andersen has 2 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
2 of the studies in Ischemic Stroke with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03160131University Hospital, Gentofte, CopenhagenRehabilitation of Visual Function After Brain Injury | 2026-12-31 |
| NCT06823466University of L'AquilaAdvancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants | 2027-02-12 |
Add all 2 to your calendar (.ics) → With an account.
Among the 51 studies in Ischemic Stroke with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to investigate whether Remote Ischemic Conditioning (RIC) improves rheo-erythrocrine dysfunction in acute ischemic stroke
Stroke is a leading cause of death and disability worldwide. Of all strokes, 85% are ischemic strokes caused by a thrombus or an embolus. The additional 15% are caused by hemorrhage. Currently the only approved treatments for ischemic strokes are thrombolysis given within 4.5 hours and thrombectomy performed within 6 hours of symptom onset - in some cases up to 24 hours. The majority of stroke patients are not however eligible for acute reperfusion therapy, mainly due to time constrains and late presentation. Novel neuroprotective strategies available for all stroke patients are thus urgently needed.
Remote Ischemic Conditioning (RIC) is a simple intervention in which transient ischemia is induced in an extremity by repetitive inflation-deflation of a blood pressure cuff. It remains uncertain exactly how the protective effect of RIC is transmitted and communicated between the extremity and the brain. Both humoral, immunological and neuronal pathways seem to be involved. Treatment with RIC and has proven to be a safe, feasible and low-cost treatment in clinical settings.
Biomarkers of the RIC treatment is a new area of stroke research and are important to establish in order to assess and predict responders of the conditioning treatment. Rheo-erythrocrine dysfunction of the Red Blood Cell (RBC) is a novel biomarker in both ischemic strokes in general and on the effect of RIC. Red Blood Cells with a diameter of 6-8 μm must be highly deformable in order to deliver oxygen to brain tissue by travelling through micro vessels with a diameter of just 2-3 μm. RBC's can carry nitric oxide as NO2-/s-nitrosylated proteins. These proteins improve RBC deformability and induce hypoxic vasodilation thereby improving passage through the microvasculature. RBC's also express Erythrocyte Nitric Oxide Synthase 3, which regulate the rheo-erythrocrine function. Erythrocyte Nitric Oxide Synthase 3 is activated by shear stress and provide an extra source of NO for hypoxic vasodilation. Preliminary data have shown that experimental stroke on mice seems to cause a rheo-erythrocrine dysfunction of the RBC's leading to a loss of deformability. The RBC's become rigid, which can lead to occlusion of micro vessels in the brain and further ischemic damage. Loss of deformability can be measured as a reduced Elongation Index (EI) by ektacytometry and may be attenuated by RIC.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Grethe Andersen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
STROKE PATIENTS
Inclusion Criteria:
Exclusion Criteria:
CONTROLS
Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remote Ischemic Conditioning (RIC) is applied during the in-hospital phase using an automated RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be 200 mmHg; if initial systolic blood pressure is above 175 mmHg, the cuff is automatically inflated to 35 mmHg above the systolic blood pressure. * Initial Remote Ischemic Conditioning: \< 2 hours from inclusion * Remote Ischemic Postconditioning: twice daily for 7 days Usual care with or without acute reperfusion therapy
Device: Remote Ischemic Conditioning
Sham Remote Ischemic Conditioning (Sham-RIC) is applied during the in-hospital phase using an automated Sham-RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be always be 20 mmHg. * Initial Sham Remote Ischemic Conditioning: \< 2 hours from inclusion * Sham Remote ischemic Postconditioning: twice daily for 7 days Usual care with or without acute reperfusion therapy.
Device: Sham Remote Ischemic Conditioning
The control group will not receive treatment with Remote Ischemic Conditioning.
RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion
Sham Comparator (Sham-RIC)
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients.
RBC deformability is measured as Deformability or Elongation Index (DI or EI, Rheoscan AnD-300, RheoMeditech, South Chorea). A higher EI at the optimum viscosity (300 Osmolality) indicates highly deformable RBCs indicative of better microcirculation, while a lower EI indicates rigid RBC's. Briefly, 6 µL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
Time frame: 1 week
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients
For measurement of shear stress, 0,5 mL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
Time frame: 1 week
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a biomarker of the conditioning response
Analytical flowcytometry with DAF-FM-Diacetate (4-Amino-5-Methylamino-2',7'-Difluorofluorescein Diacetate) on wholeblood samples
Time frame: 1 week
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a predictor of the short term clinical outcome in stroke patients
Analytical flowcytometry with DAF-FM-Diacetate (4-Amino-5-Methylamino-2',7'-Difluorofluorescein Diacetate) on wholeblood samples
Time frame: 1 week
RBC deformability presentation across stroke subtypes
Ektacytometry (see primary outcome)
Time frame: 1 week
RBC deformability in relation to infarct size/stroke severity
Ektacytometry (see primary outcome)
Time frame: 1 week
RBC erythrocrine dysfunction (NOS3) presentation across stroke subtypes
Comparison of RBC Nitric Oxide Synthestase 3 activation (flowcytometry) across stroke subtypes.
Time frame: 9 months
RBC erythrocrine dysfunction (nitric oxide) presentation across stroke subtypes
Comparison of nitric oxide estimation (chemiluminescence) across stroke subtypes
Time frame: 9 months
RBC erythrocrine dysfunction (NOS3) in relation to infarct size/stroke severity
Level of RBC Nitric Oxide Synthestase 3 activation (flowcytometry)
Time frame: 9 months
RBC erythrocrine dysfunction (nitric) in relation to infarct size/stroke severity
Level of nitric oxide estimation (chemiluminescence)
Time frame: 9 months
Difference in 7 days cognitive impairment between treatment groups
Difference between baseline Montreal Cognitive Assessment (MoCA) score and day 7 MoCA score. MoCA is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space.
Time frame: 1 week
RBC erythrocrine dysfunction and deformability as a marker for difference in 7 days cognitive impairment (MoCA scale)
Cognitive impairment is measured using the Montreal Cognitive Assessment scale (MoCA), which is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space
Time frame: 9 months
Circulating microRNA profile of RIC-induced neuroprotection
MicroRNAs will be identified with Illumina next-generation sequencing using the TruSeq Small RNA Sample Preparation kit. The output will be miRNA expression levels for each sample, which will form the basis for a miRNA differential analysis where miRNAs with statistically significant expression changes will be found
Time frame: 9 months
Extracellular vesicle profile of RIC-induced neuroprotection
Extracellular vesicles (EVs, also known as exosomes) will be isolated from plasma samples before characterization of surface markers and content. Protein characterization will be done using ELISA and Western blots in addition to array techniques. To broaden the feasibility of finding stroke type specific EV surface markers, we will utilize recombinant antibody library techniques to find novel disease binders with the potential of diagnosing stroke types in blood samples. Nucleic acid (DNA and RNA including miRNA) content of EVs will be analyzed using next generation sequencing (NGS) and qRT-PCR
Time frame: 9 months
Circulating microRNA as a marker for difference in 7 days cognitive impairment (MoCA score)
Cognitive impairment is measured using the Montreal Cognitive Assessment scale (MoCA), which is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space
Time frame: 9 months
Extracellular vesicle profile as a marker for RBC erythrocrine dysfunction and deformability
Extracellular vesicles (EVs, also known as exosomes) will be isolated from plasma samples before characterization of surface markers and content. To broaden the feasibility of finding stroke type specific EV surface markers, we will utilize recombinant antibody library techniques to find novel disease binders with the potential of diagnosing stroke types in blood samples.
Time frame: 9 months
Plan to share: No
Ran from Jul 2020 to primary completion in Jul 2021, 12 months.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 12 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Grethe Andersen